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Efficacy and Safety of TC011 in Relapsed or Refractory Follicular Lymphoma

NCT07360288 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-22

No results posted yet for this study

Summary

This Phase II, multi-center, single-arm, open-label study evaluates the efficacy and safety of TC011, a CD19-targeted CAR-T cell therapy, in adult patients with relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a).

The primary endpoint is objective response rate (ORR) assessed by independent review using the Lugano 2014 classification.

Conditions

  • Follicular Lymphoma (FL)

Interventions

BIOLOGICAL

TC011 single-arm

CD19-targeted chimeric antigen receptor T-cell therapy

Sponsors & Collaborators

  • TICAROS Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Won Seok Kim, MD, PhD · Samsung Medical Center, Department of Hematology-Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-05-31
Completion
2030-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07360288 on ClinicalTrials.gov